GingivitisNCT06910397
The Effect of Probiotics on Gums Health and Bad Breath
A study testing Probiotic Arm in people with Gingivitis, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
the study is about using healthy bacteria to improve the overall gingival and overall health and prevent or decrease the bad odor of the mouth caused by bad bacteria Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Probiotic Arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteIraq
- Study dates
- 3 Apr 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
The Inclusion criteria
- Subjects (male and female) between the age range 17-25 years old.
- Subjects with mouth breathing habit.
- Subjects with orthodontic and prosthodontic appliance
- Race from Iraq.
- Subjects having a dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant).
The Exclusion criteria
- History of chronic disease.
- History of systemic disease.
- Patients with autoimmune diseases.
- Patients under antibiotic treatment.
- Pregnant, lactating females.
- History of undergoing nonsurgical and surgical periodontal therapy in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating The Effect of Probiotics on Oral Health Status and Its Influence on The Gingival Disease and Halitosis in Iraq
the study is about using healthy bacteria to improve the overall gingival and overall health and prevent or decrease the bad odor of the mouth caused by bad bacteria
Read the detailed description
The goal of this study is to verify the effect of Probiotics on oral Health Status and eliminate the gingival disease and Halitosis by measuring the levels of salivary biomarkers (cytokine IL-1b and proteases Matrix metalloproteinase (MMP-8) in saliva) and level of volatile sulfur compounds (VSCs) and their effects on improving gingival diseases clinical parameters in person age of (17-25) years old. The participants are randomly divided into two parallel groups (A, B). Group A will take probiotics and group B will take placebo for 28 days. The levels of IL-1b, MMP-8 in saliva, and VSCs measurement will be recorded respectively in different intervals of zero time and repeated on 14 days and 28 days.
Statistical analysis will be done then comparative between two groups
- Conditions
- Gingivitis
- Being tested
- Probiotic Arm, Placebo
- Keywords
- probiotics and gingival health
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ArmDrug
one tablet daily for 28 days
PlaceboOther
placebo tablet once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| probiotic group | Active comparator | each participant will take one tablet of probiotic daily for 28 days Receives: Drug: Probiotic Arm |
| placebo group- | Placebo comparator | each participant will take one tablet of placebo tablet daily for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health measures for 90 participant of both group
gingival index (scale 0-3),plaque index (scale 0-3), oral health index- simplex is composed of the Debris index and Calculus index (scoring six tooth segments in the mouth for each participants in both groups for the study and control group.
Measured: four weeks(0day,14 day,28 day)
Halitosis (90 participant of both group)
Measuring the level of volatile sulfur compounds (VSCs) by use heliometer device (YRY Smart Breath Odor Detector), calculate social distance on (cm unite), detailed odor concentration on(ppm unite), and the related light color on the display screen for each participants in both groups the study and control group.
Measured: four weeks(0 day,14 day, 28 day)
Secondary outcomes (1)
The salivary biomarkers (90 participant of both group)
Pro-inflammatory cytokine IL-1B (pg/ml). Matrix metalloproteinase neutrophil collagenase MMP-8 (pg/ml) for each participants in both groups the study and control group.
Measured: four weeks (0 day,14 day ,28 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start3 Apr 2025
- Primary completion3 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BAYDAA ABDULQAHAR YOUNUS, Al-Mustansiriyah University
- Investigators
- BAYDAA Y Alani, MSc student, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910397
- Sponsor's protocol ID
- MUPRV13
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Effect of Probiotics on Oral Health Status and Its Influence on The Gingival Disease and Halitosis in Iraq
- ClinicalTrials.gov ID
- NCT06910397
- Acronym / sponsor ID
- MUPRV13
- Conditions
- Gingivitis
- Keywords
- probiotics and gingival health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 3 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study is about using healthy bacteria to improve the overall gingival and overall health and prevent or decrease the bad odor of the mouth caused by bad bacteria
Detailed description
The goal of this study is to verify the effect of Probiotics on oral Health Status and eliminate the gingival disease and Halitosis by measuring the levels of salivary biomarkers (cytokine IL-1b and proteases Matrix metalloproteinase (MMP-8) in saliva) and level of volatile sulfur compounds (VSCs) and their effects on improving gingival diseases clinical parameters in person age of (17-25) years old. The participants are randomly divided into two parallel groups (A, B). Group A will take probiotics and group B will take placebo for 28 days. The levels of IL-1b, MMP-8 in saliva, and VSCs measurement will be recorded respectively in different intervals of zero time and repeated on 14 days and 28 days.
Statistical analysis will be done then comparative between two groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic group | Active comparator | Drug: Probiotic Armeach participant will take one tablet of probiotic daily for 28 days |
| placebo group- | Placebo comparator | Other: Placeboeach participant will take one tablet of placebo tablet daily for 28 days |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Armone tablet daily for 28 days | Drug | probiotic group |
| Placeboplacebo tablet once daily for 28 days | Other | placebo group- |
Primary outcome
oral health measures for 90 participant of both group
Time frame: four weeks(0day,14 day,28 day)
gingival index (scale 0-3),plaque index (scale 0-3), oral health index- simplex is composed of the Debris index and Calculus index (scoring six tooth segments in the mouth for each participants in both groups for the study and control group.
Halitosis (90 participant of both group)
Time frame: four weeks(0 day,14 day, 28 day)
Measuring the level of volatile sulfur compounds (VSCs) by use heliometer device (YRY Smart Breath Odor Detector), calculate social distance on (cm unite), detailed odor concentration on(ppm unite), and the related light color on the display screen for each participants in both groups the study and control group.
1 secondary outcome
The salivary biomarkers (90 participant of both group)
Time frame: four weeks (0 day,14 day ,28 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BAYDAA Y Alani, MSc student principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Arm in people with Gingivitis, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health measures for 90 participant of both group (time frame: four weeks(0day,14 day,28 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.